FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE), and the National Cancer Institute Gynecologic Oncology Group (COG-19), showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an Erythropoiesis-Stimulating Agent (ESA). Both the PREPARE study in breast cancer and the COG-19 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA. FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival in patients with cancer before starting or continuing ESA therapy.
